In diagnosing and treating certain medical conditions, it is often desirable to perform a biopsy, in which a specimen or sample of tissue is removed for pathological examination, tests and analysis. A biopsy typically results in a biopsy cavity occupying the space formerly occupied by the tissue that was removed. As is known, obtaining a tissue sample by biopsy and the subsequent examination are typically employed in the diagnosis of cancers and other malignant tumors, or to confirm that a suspected lesion or tumor is not malignant. Treatment of cancers identified by biopsy may include subsequent removal of tissue surrounding the biopsy site, leaving an enlarged cavity in the patient's body. Cancerous tissue is often treated by application of radiation, by chemotherapy, or by thermal treatment (e.g., local heating, cryogenic therapy, and other treatments to heat, cool, or freeze tissue).
Cancer treatment may be directed to a natural cavity, or to a cavity in a patient's body from which tissue has been removed, typically following removal of cancerous tissue during a biopsy or surgical procedure. For example U.S. Pat. No. 6,923,754 to Lubock and U.S. patent application Ser. No. 10/849,410 to Lubock, describe devices for implantation into a cavity resulting from the removal of cancerous tissue which can be used to deliver cancer treatments to surrounding tissue. One form of radiation treatment used to treat cancer near a body cavity remaining following removal of tissue is “brachytherapy” in which a source of radiation is placed near to the site to be treated.
The Lubock patent and patent application, above, describe implantable devices for treating tissue surrounding a cavity left by surgical removal of cancerous or other tissue that includes a cavity filling member such as an inflatable balloon constructed for placement in the cavity. The Lubock devices develop a vacuum within the biopsy cavity that is effective to draw surrounding tissue close to the surface of a treatment assembly so as to conform the tissue lining the cavity to the surface of the balloon. Such devices may be used to apply one or more of radiation therapy, chemotherapy, and thermal therapy to the tissue surrounding the cavity from which the tissue was removed. The balloon may be filled with a treatment fluid delivered via a conduit from a receptacle, syringe, or other means, or may receive a solid radiation source placed within the balloon.
For example, a “MammoSite® Radiation Therapy System” (MammoSite® RTS, Proxima Therapeutics, Inc., Alpharetta, Ga. 30005 USA) includes a balloon catheter with a radiation source that can be placed within a tumor resection cavity in a breast after a lumpectomy. It can deliver a prescribed dose of radiation from inside the tumor resection cavity to the tissue surrounding the original tumor. Inflatable treatment delivery devices and systems, such as the MammoSite® RTS and similar devices and systems (e.g., GliaSite® RTS (Proxima Therapeutics, Inc.)), are useful to treat cancer in tissue adjacent a body cavity.
Long term deployment of the catheter within the biopsy site may be necessary, e.g. for a few days to a few weeks to maintain access to the biopsy cavity while the biopsy sample is analyzed and it is determined whether or not irradiation of the cavity is necessary. The irradiation is not always necessary for a body cavity formed after removal of tissue. When irradiation is not needed the catheters are removed and disposed of. When in place within the patient, the proximal ends of the prior art catheters extend out of the patient providing direct access for infections to reach the biopsy site.
The prior catheters are expensive and a catheter used only to hold the shape of the biopsy cavity is disposed of afterwards. Thus there is need in the art for less expensive devices which are temporary and capable of maintaining access to the biopsy device with reduced risk of infection.